OncBioMune Pharmaceuticals is a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in early 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
We are a clinical-stage biopharmaceutical company engaged in the development of novel cancer immunotherapy products, with a proprietary Vaccine Technology that is designed to stimulate the immune system to attack its own cancer while not hurting the patient. Our lead product, ProscaVax™ is scheduled to commence a Phase 2 clinical study in early 2016. OncBioMune also has a portfolio of targeted therapies, some of which are biosimilars to blockbuster drugs. OncBioMune is headquartered in Baton Rouge, LA.
Dr. Jonathan Head, Ph.D.
CHIEF EXECUTIVE OFFICER, CHAIRMAN
Dr. Head has been instrumental in the development of our new chemotherapy and immunotherapy programs. Dr. Head and Dr. Elliott are the co-developers and patent holders of one of the first patented autologous breast cancer vaccines in the United States. His major goal is to implement translational research – the movement of laboratory-developed technologies into the clinical setting. This is the taking of new therapies from cell culture to an accepted therapy for cancer patients.
As a tumor cell biologist, Dr. Head’s specialties include:
- Cell culture research
- Animal research
- Human clinical research
- Innovative chemotherapies
- Immunotherapy/cancer vaccines
- Oncogene and antisense research
- Tumor markers
Dr. Head is an Adjunct Associate Professor of Biochemistry at Tulane University School of Medicine, an Adjunct Professor of Physical and Biological Sciences at Delta State University and an Adjunct Associate Professor at Louisiana State University School of Veterinary Medicine. He is an active member of the American Association for Cancer Research and the American Society of Clinical Oncology. Although patients rarely meet Dr. Head, the new treatments we offer are the result of his and Dr. Elliott’s work.
Dr. Robert Elliott, M.D., Ph.D.
CHIEF MEDICAL OFFICER, DIRECTOR
Dr. Robert Elliott is the driving force behind our The Elliott-Elliott-Head Breast Cancer Research and Treatment Center. Colleagues often remark that his energy seems boundless. Indeed, it often is.
In 1973, when the Center was founded, Dr. Elliott’s dream was to create the finest center for total breast care. With that step behind us, the dream continues. Dr. Elliott continues doing research to discover new treatments and drug therapies, and has implemented a team approach to bring total breast care to the patients.
Dr. Elliott sees patients from all over Louisiana, the Southeast and across the United States. He collaborates on research projects with other scientists around the world. Dr. Elliott has spoken to medical audiences in the United States and Europe and has authored many papers and abstracts. He has also published a book, Breast Cancer, Anger at the Enemy, which deals with the lack of total breast care available for women. He shares his own frustration and heartaches of caring for dying cancer patients as they struggle for survival, and finally sends a message of hope as he and his research team search for a cure for breast cancer.
Trained as a general surgeon, Dr. Elliott feels that breast care should be a specialty of itself, with patients being able to receive the highest quality of care from one physician who reads their mammograms, examines them, performs their surgery and administers their therapies.
To advance this concept and to share his experience with other physicians like himself who specialize in breast care, Dr. Elliott founded the American Mastology Association. He currently serves as President of this society. In spite of a busy calendar of meetings and research, Dr. Elliott’s first love is his patients. He devotes the majority of his time to the Center and to helping women overcome breast disease.
CHIEF FINANCIAL OFFICER, PRESIDENT, DIRECTOR
Andrew “Al” Kucharchuk is a graduate of Louisiana State and Tulane Universities Freeman School of Business, where he earned an MBA with a Finance Concentration. He currently serves as the Company’s Chief Financial Officer and oversees the business and administrative processes. In addition to these duties, Al also directs business development efforts including the expansion of operations to accommodate increased research and clinical development. Al has assisted Dr. Head in the administration of the three contracts that have lead to the clinical studies for the Company’s lead product, ProscaVax™.
Mr. Kucharchuk is a member of Kappa Alpha Order fraternity. He lives in Baton Rouge with his wife Jessica and their sons Henry and Davis.
Charles L. Rice, Jr.
Mr. Rice is the President and Chief Executive Officer of Entergy New Orleans, Inc., an $800 million a year electric and gas utility and subsidiary of NYSE-listed Entergy Corporation. After his first legal private practice position in Louisiana with Jones, Walker, Waechter, Poitevent, Carrere & Denegre, L.L.P, Rice joined Entergy in the legal department in 2000, serving as senior counsel in the Entergy Services, Inc. litigation group and then as manager of labor relations litigation support in human resources.
Rice was recruited into New Orleans city government in 2002 as the city attorney and later took the critical role of chief administrative officer for the City of New Orleans, where he managed 6,000 employees and the city’s $600 million budget. In 2005, the law firm of Barrasso, Usdin, Kupperman, Freeman & Sarver, L.L.C. recruited him back to private practice, where he was named partner.
Returning to Entergy in 2009, Rice served as director of utility strategy where he was responsible for coordinating regulatory, legislative, and communications efforts to develop and execute strategies that advanced commercial objectives for the company’s regulated service areas. He then served as director of regulatory affairs for Entergy New Orleans.
Rice holds a bachelor’s degree in business administration from Howard University, a juris doctorate from Loyola University’s School of Law and master’s degree in business administration from Tulane University. After graduating from Howard University, he was commissioned as a second lieutenant in the United States Army and served as a military intelligence officer with the 101st Airborne Division (Air Assault) at Fort Campbell, KY. While in the Army, he earned the Airborne Badge, Air Assault badge and was awarded the Army Commendation and the Army Achievement medals.
He is a member of the Alabama and Louisiana State Bar Associations, the American Bar Association, the New Orleans Bar Association, and the National Bar Association.
Daniel Hoverman is a Director at NYSE-listed Houlihan Lokey, a leading global investment bank, where he is a senior member of the firm’s Corporate Finance Group. Mr. Hoverman is also actively involved with Houlihan Lokey’s efforts in equity capital markets.
Mr. Hoverman has extensive mergers and acquisitions advisory and financing experience, having completed over $100 billion of transactions for both private and public companies across multiple industries and geographies. Before joining Houlihan Lokey, he was a Director with Credit Suisse in Hong Kong as a member of the office of the General Counsel, and was responsible for oversight and management of investment banking transactions. Prior to Credit Suisse, he was a Director with UBS Investment Bank in New York as a member of the firm’s Equity Capital Markets Group and Equity Corporate Finance Team, where he was responsible for origination, oversight and management of securities offerings. He began his career with Kirkland & Ellis LLP as a corporate attorney focusing on capital markets and mergers and acquisition transactions.
Mr. Hoverman received a B.A. from Yale University, where he graduated cum laude with distinction in history and was a Robert C. Bates Fellow and New Prize recipient, and received a J.D. and M.B.A. from Columbia University, where he was a James Kent Scholar and a John C. Olin Fellow. Mr. Hoverman holds Series 7, 24, 63 and 79 licenses and the designation of Chartered Financial Analyst, and is an inactive member of the New York Bar.
Dr. J. Jacques Carter
SCIENTIFIC ADVISORY BOARD MEMBER
Dr. Carter currently serves as a physician at the Beth Israel Deaconess Medical Center in Boston, MA and is an assistant professor at Harvard Medical School. From 2005 to 2014, he also served as the Medical Director of the Prostate Cancer Screening and Education Program at the Dana-Farber Cancer Institute.
Dr. Carter completed his residency training in Internal Medicine at Beth Israel Deaconess Medical Center in Boston, followed by a graduate program at the Harvard School of Public Health, where he received his MPH degree. He then completed a clinical fellowship in Primary Care Medicine at the Massachusetts General Hospital.
Dr. Carter has held a number of clinical and administrative positions, including Medical Directorships of several local and national health care organizations. A former director of one of the major clerkships, he now serves as a teacher/advisor/mentor for students at Harvard Medical School and the Harvard School of Public Health. Dr. Carter has been active in a number of civic and community organizations, including past president of the board of Family Service of Greater Boston and past chair of the Brookline Advisory Council on Public Health. He regularly gives talks on medical and health related issues to community groups and students throughout greater Boston. He also lectures nationally and internationally on medical and public health topics. Dr. Carter serves as a medical consultant and resource for members of the media. He is a past President of the Harvard School of Public Health Alumni Association and a current director of the Harvard Alumni Association. Dr. Carter is a founding member of the Georgetown University African American Advisory Board. He is the recipient of the 2010 Harvard Medical School/Harvard School of Dental Medicine Community Service Lifetime Achievement Award. His bio has been included in “Who’s Who in the East, “Who’s Who in Medicine and Healthcare”, Who’s Who in Science and Engineering, and “Who’s Who in America”.
¹Upon completion of a successful Phase 1 study, the Company plans to begin a Phase 2 study at Harvard Cancer Centers.
ProscaVax – A Novel Prostate Cancer Vaccine
The Company has developed a therapeutic cancer vaccine for prostate cancer patients using similar techniques developed for breast cancer patients. It is tested and laboratory proven and could become the standard of care for prostate cancer treatment. The Company incorporates scientifically proven and clinically validated treatments for cancer. We utilize patented technology developed and or acquired by OncBioMune. The intellectual property consists of multiple technologies combined with laboratory and clinical procedures that provide new insight into the treatment of cancer. The Company’s proprietary technology provides the necessary tools for the successful treatment of patient’s with a therapeutic vaccine. It is marketable and would be very profitable upon FDA approval.
The Company has data from a phase 1/2 clinical trial of their therapeutic prostate cancer vaccine. Patients with prostate cancer confirmed by biopsy and with an elevated PSA received the vaccine. We enrolled 12 patients in this study. All patients received their initial course of six vaccinations containing prostate specific antigen and biological adjuvant. Serum PSA concentrations were determined before initiating vaccination and 3-4 weeks after the 6th vaccination. Two-thirds of the prostate cancer patients’ PSAs decreased after vaccination. During the trial the prostate cancer patients received no other concurrent therapy (surgery, hormone, radiation, radioactive seeds, chemotherapy), and have additionally received three further vaccinations alternated with low dose IL-2 for the 6 months following the initial vaccinations. The Company developed the protocol for the vaccination of prostate cancer patients using techniques developed for vaccination of breast cancer patients. We are currently in a Phase 1 clinical trial at UCSD Medical School under an IND from the FDA with funding from the US Navy Cancer Vaccine Program. If proven effective clinically, it could become the standard of care for prostate cancer.
Information on the current clinical trial of ProscaVax can be found on the clinictrials.gov at https://clinicaltrials.gov/ct2/show/NCT02058680?term=oncbiomune&rank=1.
Breast cancers and other epithelial malignancies are antigenic and elicit lymphocyte responses in the autologous host, and patients that express good host immunity to their tumor have better survival. Adequate host immunity is an independent prognostic indicator and those with poor immunity have shorter disease free intervals and shorter overall survival. The Company’s novel approach defines the tumor specific immune status of patients both pre and post immunotherapy that uses autologous tumor antigens to immunize patients. We have the ability to discriminate patients who are immunologically unreactive to tumor antigens and may be generally lymphocyte depressed from those who are tumor antigen reactive and lymphocyte competent. Thus those patients who are unreactive and in need of immunostimulation qualify for vaccination with specific tumor antigen .
We developed our vaccine in 1993 and then immediately began vaccinating patients with depressed immunity. We obtained the first patent on a breast cancer vaccine in the U.S.A. in 1994, and were the first to use the cytokines GM-CSF and IL-2 as biological adjuvants. Appropriate patients are vaccinated in the adjuvant setting and patients with advanced disease are treated with a combined chemo-immunotherapy protocol. Some of these patients have had dramatic responses.
The Company is presently devoting much research to the tumor stroma and microenvironment for a better understanding of tumor escape mechanisms. This will allow us the ability to better attack the tumor with specific adaptive immunotherapy. This work is in progress and early results are producing exciting results.
“Targeted Transferrin Transport Technology”
The Company has developed a strategy to increase the efficacy and lessen the toxicity of cancer chemotherapy by binding heavy metals and coupling chemotherapeutic drugs to the serum protein transferrin. Transferrin is the serum protein that transports iron to sites of absorption, utilization and storage. Iron is an essential micronutrient for DNA synthesis, and all cancer cells require very large amounts of iron for DNA synthesis and rapid cell growth. Cancer cells express 100 to 1,000-fold greater numbers of transferrin receptors on their cell surface than normal cells.
Therefore, with our transferrin transport technology (TTT), we can deliver cytotoxic agents targeted selectively to the cancer cell, and thus, have little effect on normal cells.
Our transferrin compounds are of three types:
- Heavy metals bound to the physiologic binding sites of the transferrin molecule
Drugs conjugated to the molecule by a gluteraldehyde coupling process.
Drugs trapped in protein molecules.
These agents alone and in combination with other cancer therapies, demonstrate tremendous cancer cell killing with little effect on normal cells. They have been shown to potentiate the effect and lessen the toxicity of conventional chemotherapy if given as pretreatment prior to the chemotherapy. One of the compounds (cis-platinum-transferrin) has been shown to be an especially good radiation sensitizer, and potentiate the effects of doxorubucin when used as a pretreatment agent.
The Company is also involved in attacking iron metabolism of cancer cells by many other approaches. We disrupt intracellular iron metabolic pathways and prevent iron storage into the protein ferritin. We have technology to modulate transferrin receptors on the surface of cancer cells, which gives us much flexibility in using all of our approaches. Some of the intracellular methods use our antisense technology, which will be discussed in the section on antisense.
Antisense oligonucleotide are defined as the oligodeoxyribonucleotide (oDNA) sequence that is complementary to the DNA or RNA sequence of the target gene. Antisense RNA defined as the antisense cDNA, which is complementary to the RNA sequence of the gene.
- A design of antisense can recognize precise DNA location in a gene
Antisense can be equipped to recognize a single mRNA species among a myriad of mRNAs
Antisense can discriminate between the genetic information of normal and mutated oncogenes in cancer cells.
The use of antisense oligonucleotides, as discriminating inhibitors of gene expression resulting in decrease tumor growth, offers a novel approach to the treatment of cancer. In the antisense approach, oligonucleotides complementary to specific sequences target the mRNA involved in important cellular functions and protein production. The therapeutic application of the antisense approach is currently under exploration in many different fields including oncology and immunology. Nuclease degradation is a major limitation for the use of oligonucleotides as therapeutic agents.
The strategy behind antisense therapy is the development of specific therapeutic agents that aim to correct the mutations and abnormal expression of cellular genes in tumor cells by decreasing gene expression, inducing degradation of target mRNA and causing premature termination of transcription. Many in vitro and in vivo studies have investigated the therapeutic efficacy of oligonucleotides and antisense RNAs. These studies have demonstrated specific inhibition of tumor cell growth by antisense therapy and have shown synergistic inhibitory effects between antisense oligonucleotides or antisense RNA and conventional chemotherapeutic drugs used in the treatment of cancer. Antisense oligonucleotides with modifications will improve their ability to penetrate cells, bind to gene sequences and disrupt target gene function. Many delivery systems for antisense RNA and antisense oligonucleotides have been developed, including virus vectors (retrovirus, adenovirus and adeno-associate virus) and liposomes, to carry the antisense RNA or oligonucleotides through the cell membrane into the cytoplasm and nucleus of the tumor cells. Various studies showed that antisense therapies directed at abnormal genes in breast cancer are potentially useful in the treatment of cancer. Many antisense therapeutic strategies are under development and provide a basis for a better understanding of the mechanisms of gene regulation and growth inhibition in human cancer. The ability to benefit from these characteristics presents a unique opportunity in treating all cancers.
The developing ability to mass produce antisense will allow the creation of antisense that will improve the regulation of gene expression, will reduce toxicity, and improve delivery systems.
| ||Market Value1 ||$82,843,998 ||a/o Feb 09, 2016 |
| ||Authorized Shares ||450,000,000 ||a/o Sep 29, 2015 |
| ||Outstanding Shares ||54,502,630 ||a/o Nov 16, 2015 |
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OncBioMune Pharmaceuticals Inc.
11441 Industriplex Blvd.
Baton Rouge, LA 70809
Corporate Office: 1-225-227-2384